An observational study in Perianal Fistula, sponsored by Azienda Ospedaliero, Universitaria Pisana. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Observational
The study aims to evaluate the efficacy of the local injection of autologous micro-fragmented adipose tissue obtained with the Lipogems®system in patients with trans-sphincteric fistulas untreatable with fistulotomy.
STUDY BACKGROUND
Perianal fistulas are diseases that, by their nature, do not tend to heal spontaneously and are very rarely cured with medical treatment. Their healing is usually pursued through surgery, which often needs to be repeated due to the natural tendency of the fistulas to recur. A surgical treatment that is currently able to provide a high chance of healing is fistulotomy which, however, can injure the anal sphincter and may result in degrading scars and possible fecal incontinence. One possible strategy could be the lipofilling, i.e., autologous adipose tissue transplant containing, among the many, pericytes and progenitor cells, including adult mesenchymal stem cells.
STUDY DESIGN
This is a no profit interventional prospective multicenter study without drugs where 100 patients (10 each participant centre) with a diagnosis of trans-sphincteric anal fistula that is not suitable to be laid open will be enrolled.
After the enrolment, medical history and clinical data will be collected and pre-operatory exams will be performed.
METHODS
The lower/lateral abdomen or, eventually, the inner/outer thigh will be chosen as donor site for adipose tissue harvesting under general or spinal anaesthesia. Before the harvesting, the donor site will be injected with 100 cc of Klein Solution (500 cc saline, 1 cc epinephrine 1/1000 IU, and 40 cc lidocaine 2%) using a disposable 17 gauge blunt cannula connected to a 60-cc luer-lock syringe. The fat will be then harvested (50-100 cc) using a 13 gauge blunt cannula connected to a 20-ml VacLok® syringe.
The harvested fat will be immediately processed in the Lipogems® processing kit (Lipogems International Spa, Milan, Italy). Lipogems® is a disposable device that mechanically reduces the size of the adipose tissue clusters while eliminating oily substances and blood residues with pro-inflammatory properties. The entire process is carried out in one surgical step in complete immersion in physiological solution minimizing any traumatic action on the cells and microarchitecture. The processed micro-fragmented fat will be collected in a 60-cc syringe and positioned to decant the excess of saline solution. At the end, the product will be transferred in several 5-cc syringes to be re-injected in the patient.
The micro-fragmented autologous adipose tissue will be injected with wheals of no more than 1cc in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice.
All patients will be assessed at 7 days, 1, 3, 6 and 12 months after the procedure.
189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.
This study's planned enrollment of 100 is close to the median of 94 across 50 observational studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 56 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of transphincteric anal fistula that is not suitable to be laid open.
Exclusion Criteria:
Lipogems injection in the internal orifice, mucosal, submucosal and muscular layer, in the fistula tract and external orifice.
Procedure: Lipogems
Autologous micro-fragmented adipose tissue is injected in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice in addition to anal flap.
Healing
Closing of the fistula tract (internal and external orifice)
Time frame: 12 months
Safety collecting all types of adverse events
All types of adverse events intra-, peri-, or post-operative will be collected
Time frame: 12 months
Pain assessed using the Visual Analogue Scale (VAS) for pain
Pain will be assessed using the Visual Analogue Scale for pain (VAS 0-10), where 0 is no pain and 10 is the maximum pain.
Time frame: 12 months
Continence
Continence will be assessed with the Wexner Continence Grading Scale. The score takes into account the type and frequency of incontinence and the extent to which it alters the patient's life. This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence).
Time frame: 12 months
Patient's satisfaction
Patient's satisfaction will be evaluated using a visual analogue scale 0-5, where 0 is no satisfaction and 5 is maximum satisfaction.
Time frame: 12 months
Non inferiority compared with the Advancement flap technique
Non-inferiority will be determined comparing healing rate of Lipogems with retrospective data on the advancement flap.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliero, Universitaria Pisana